Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
Interventions
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
HRS9531 injection compared with placebo and open positive-controlled group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months. 3. Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. 4. 7.0% ≤ HbA1c ≤10.5% at screening.
Exclusion criteria
1. History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) or episode of severe hypoglycaemic events within 12 months prior to screening. 4. Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial; 5. Participants in clinical trials of any drug or medical device in the 3 months prior to screening. 6. Breast-feeding women. 7. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (Safety and Tolerability) | Screening period up to Day 62 | A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) of HRS9531 | Start of Treatment up to Day 62 |
| Change from Baseline in Fasting Blood Glucose (FBG) | Baseline up to Day 62 |
| Area Under the Concentration Versus Time Curve (AUC) of HRS9531 | Start of Treatment up to Day 62 |
| Change from Baseline in Weight | Baseline up to Day 62 |
| Immunogenicity: anti-HRS9531 antibody | Start of Treatment up to Day 62 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline up to Day 29 |
Countries
China
Outcome results
None listed